罗氏 cobas 6000 生化免疫分析仪简易操作手册

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罗氏 cobas e 801 电化学发光免疫分析仪使用说明书 - 检测抗 HBs 抗体的试剂盒

Elecsys Anti-HBs IIREFSYSTEM********************** 300cobas e 801EnglishSystem information Short name ACN (application code number) AHBS 2 10138 Immunoassay for the in vitro quantitative determination of human antibodies to the hepatitis B surface antigen (HBsAg) in human serum and plasma.Anti-HBs assays are used within the scope of hepatitis B vaccination to check the necessity and success of vaccination. In addition, anti-HBs assays are used to monitor the course of disease following acute hepatitis B infection. This test is not intended for diagnosis.The e lectro c hemi l uminescence i mmuno a ssay “ECLIA” is intended for use on the cobas e 801 immunoassay analyzer.Note: Please note that the catalogue number appearing on the package insert retains only the first 8 digits of the licensed 11-digit Catalogue Number: 07026854190 for the Elecsys Anti-HBs II assay. The last 3 digits -190 have been replaced by -119 for logistic purposes. SummaryAnti-HBs is a specific (generally IgG) antibody that is directed against the hepatitis B surface antigen (HBsAg).1,2 Anti ‑HBs can be detected several weeks after the disappearance of hepatitis B surface antigen.3,4 Anti ‑HBs can be formed following a hepatitis B infection or after hepatitis Bvaccination.3,4 Antibodies are formed against the HBsAg determinant a, which is common to all subtypes, and against subtype-specific determinants.1,5,6Anti ‑HBs assays are used within the scope of hepatitis B vaccination to check the necessity and success of vaccination.2,4,7 In addition, anti ‑HBs assays are used to monitor the course of disease following acute hepatitis B infection.3The Elecsys Anti ‑HBs II assay uses a mixture of purified antigens fromhuman serum (HBsAg subtype ad), and recombinant HBsAg subtype ay from CHO (Chinese Hamster Ovary) cells. Test principleSandwich principle. Total duration of assay: 18 minutes.▪ 1st incubation: Anti ‑HBs in the sample (24 μL), biotinylated HBsAg(ad/ay), and HBsAg (ad/ay) labeled with a ruthenium complex a) react to form a sandwich complex.▪ 2nd incubation: After addition of streptavidin-coated microparticles, thecomplex becomes bound to the solid phase via interaction of biotin and streptavidin.▪ The reaction mixture is aspirated into the measuring cell where themicroparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell II M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.▪ Results are determined via a calibration curve which is instrument-specifically generated by 2‑point calibration and a master curve provided via the cobas link.a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy)32+)Reagents – working solutionsThe cobas e pack (M, R1, R2) is labeled as AHBS 2. M Streptavidin-coated microparticles, 1 bottle, 13.2 mL:Streptavidin-coated microparticles 0.72 mg/mL; preservative. R1 HBsAg~biotin, 1 bottle, 16.7 mL:Biotinylated HBsAg (ad/ay) human/recombinant, > 0.5 mg/L; MES b) buffer 85 mmol/L, pH 6.5; preservative. R2 HBsAg~Ru(bpy)32+, 1 bottle, 15.8 mL:HBsAg (ad/ay) human/recombinant, labeled with ruthenium complex > 0.3 mg/L; MES buffer 85 mmol/L, pH 6.5; preservative.b) MES = 2-morpholino-ethane sulfonic acidAHBS 2 Cal1 Calibrator 1, 1 bottle of 1.3 mL:Anti ‑HBs (human) in human serum; preservative.AHBS 2 Cal2 Calibrator 2, 1 bottle of 1.3 mL:Anti ‑HBs (human) in human serum; preservative.Precautions and warnings For in vitro diagnostic use.Exercise the normal precautions required for handling all laboratory reagents. Disposal of all waste material should be in accordance with local guidelines. Safety data sheet available for professional user on request.This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:n ‑Octyl ‑N,N ‑dimethyl ‑3‑ammonio ‑1‑propanesulfonateEUH 208 May produce an allergic reaction.Product safety labeling primarily follows EU GHS guidance. All human material should be considered potentially infectious.The calibrators (AHBS 2 Cal1 and AHBS 2 Cal2) have been preparedexclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA ‑approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.The HBsAg starting material used was inactivated prior to labeling with biotin or ruthenium by heating to 60 °C for 15 hours. In addition, any virus particles remaining were removed by ultracentrifugation.However, as no inactivation or testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.8,9 Avoid foam formation in all reagents and sample types (specimens, calibrators and controls). Reagent handlingThe reagents (M, R1, R2) in the kit are ready-for-use and are supplied in cobas e packs. CalibratorsThe calibrators are supplied ready ‑for ‑use in bottles compatible with the system.Unless the entire volume is necessary for calibration on the analyzer, transfer aliquots of the ready ‑for ‑use calibrators into empty snap ‑cap bottles (CalSet Vials). Attach the supplied labels to these additional bottles. Store the aliquots at 2‑8 °C for later use.Perform only one calibration procedure per aliquot.All information required for correct operation is available via the cobas link. Storage and stability Store at 2‑8 °C. Do not freeze.Store the cobas e pack upright in order to ensure complete availability of the microparticles during automatic mixing prior to use. Stability of the cobas e pack: unopened at 2‑8 °Cup to the stated expiration date on the cobas e 801 analyzer 16 weeksStability of the calibrators: unopened at 2‑8 °C up to the stated expiration date after opening at 2‑8 °C 16 weeks on the cobas e 801 analyzer at 20‑25 °Cuse only onceadhering to the snap ‑cap.Specimen collection and preparationOnly the specimens listed below were tested and found acceptable.Serum collected using standard sampling tubes or tubes containing separating gel.K2‑EDTA and K3‑EDTA plasma.Criterion: Slope 1.00 ± 0.15 + intercept 0 ± 2 IU/L + bias at 10 IU/L: ≤ 30 %. Stable for 3 days at 20‑25 °C, 6 days at 2‑8 °C, 3 months at ‑20 °C(± 5 °C). The samples may be frozen 5 times.For plasma treated with lithium heparin, lithium heparin with gel or sodium heparin, the values found were on average up to 20 % lower than those obtained in serum. For plasma treated with sodium citrate, the values found were on average up to 30 % lower than those obtained with serum.The sample types listed were tested with a selection of sample collection tubes or systems that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.Centrifuge samples containing precipitates and thawed samples before performing the assay.Do not use heat‑inactivated samples.Do not use samples and controls stabilized with azide.Ensure the samples and calibrators are at 20‑25 °C prior to measurement. Due to possible evaporation effects, samples and calibrators on the analyzers should be analyzed/measured within 2 hours.The performance of the Elecsys Anti‑HBs II assay has not been established with cadaveric samples or body fluids other than serum and plasma. Materials providedSee “Reagents –working solutions” section for reagents.▪ 2 x 6 bottle labelsMaterials required (but not provided)▪REF 11876317122, PreciControl Anti‑HBs, 16 x 1.3 mL▪REF 11776576322, CalSet Vials, 2 x 56 empty snap-cap bottles▪REF***********,DiluentUniversal,45.2mLsamplediluent▪▪cobas e 801 analyzerAccessories for the cobas e 801 analyzer:▪REF***********,ProCellIIM,2x2Lsystemsolution▪REF 04880293190, CleanCell M, 2 x 2 L measuring cell cleaning solution ▪REF***********,ReservoirCups,8cupstosupplyProCellIIMand CleanCell M▪REF***********,PreCleanIIM,2x2Lwashsolution▪REF***********,AssayTip/AssayCuptray,6magazinesx6magazine stacks x 105 assay tips and 105 assay cups, 3 wasteliners▪REF***********,LiquidFlowCleaningCup,2adaptorcupstosupply ISE Cleaning Solution/Elecsys SysClean for Liquid Flow CleaningDetection Unit▪REF***********,PreWashLiquidFlowCleaningCup,1adaptorcupto supply ISE Cleaning Solution/Elecsys SysClean for Liquid Flow Cleaning PreWash Unit▪REF 11298500316, ISE Cleaning Solution/Elecsys SysClean,5 x 100 mL system cleaning solutionAssayFor optimum performance of the assay follow the directions given in this document for the analyzer concerned. Refer to the appropriate operator’s manual for analyzer‑specific assay instructions.Resuspension of the microparticles takes place automatically prior to use. Place the cooled (stored at 2‑8 °C) cobas e pack on the reagent manager. Avoid foam formation. The system automatically regulates the temperature of the reagents and the opening/closing of the cobas e pack. Calibrators:Place the calibrators in the sample zone.Read in all the information necessary for calibrating the assay.CalibrationTraceability: This method has been standardized against the 1st WHO Reference Standard 1977.The predefined master curve is adapted to the analyzer using AHBS 2 Cal1 and AHBS 2 Cal2.Calibration frequency: Calibration must be performed once per reagent lot using AHBS 2 Cal1, AHBS 2 Cal2 and fresh reagent (i.e. not more than24 hours since the reagent kit was registered on the analyzer).Renewed calibration is recommended as follows:▪after 12 weeks when using the same reagent lot▪after 28 days when using the same cobas e pack on the analyzer▪as required: e.g. quality control findings with PreciControl Anti‑HBs outside the defined limitsQuality controlFor quality control, use PreciControl Anti‑HBs.Controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per cobas e pack, and following each calibration.The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.If necessary, repeat the measurement of the samples concerned.Follow the applicable government regulations and local guidelines for quality control.CalculationThe analyzer automatically calculates the analyte concentration of each sample in IU/L.Interpretation of the resultsNumeric result Result message Interpretation< 10 IU/L Non-reactive Negative for anti-HBs≥ 10 IU/L Reactive Positive for anti-HBsvary depending on the testing procedure used. Results obtained from a single sample using tests from different manufacturers can therefore differ by up to a factor of 4 (or even a factor of 10 in rare cases). If there is a change in the assay procedure used during the monitoring of vaccination protection, then the anti‑HBs values obtained upon changing over to the new method must be confirmed by parallel measurements by both methods. Vaccination strategies in certain risk groups are based on the measured anti‑HBs concentration. Respective recommendations are given by national or regional guidelines. Limitations - interferenceThe effect of the following endogenous substances and pharmaceutical compounds on assay performance was tested. Interferences were tested up to the listed concentrations and no impact on results was observed. Endogenous substancesCompound Concentration testedBilirubin ≤ 513 μmol/L or ≤ 30 mg/dL Hemoglobin ≤ 0.621 mmol/L or ≤ 1000 mg/dL Intralipid ≤ 1500 mg/dLBiotin ≤ 41 nmol/L or ≤ 10 ng/mL Rheumatoid factors ≤ 1200 IU/mLAlbumin ≤ 7.0 g/dLIgG ≤ 7.0 g/dLIgA ≤ 1.6 g/dLIgM ≤ 1.0 g/dL2 / 42017-09, V 1.0 Can EnglishCriterion: Recovery for samples from Limit of Detection to 10 IU/L:≤ ± 2 IU/L, and samples > 10 IU/L: ≤ ± 20 % of initial value.Samples should not be taken from patients receiving therapy with high biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin administration.Pharmaceutical substancesIn vitro tests were performed on 16 commonly used pharmaceuticals. No interference with the assay was found.In addition, the following special drugs used in hepatitis B therapy were tested. No interference with the assay was found.Special drugsDrug Concentration testedmg/LPeginterferon alfa‑2a ≤ 0.18Peginterferon alfa‑2b ≤ 1.6Lamivudine ≤ 300Adefovir ≤ 10Entecavir ≤ 10Tenofovir ≤ 600Telbivudine ≤ 245Due to high-dose hook effect c), results from anti‑HBs concentrations of> 200000 IU/L may be found below the upper limit of the measuring range of 1000 IU/L. In rare cases, a high-dose hook effect from anti HBs concentrations of < 20000 IU/L cannot be excluded. Therefore in case of any unexpected low result the sample should be diluted 1:100 (refer to chapter “Dilution”) and tested again.In rare cases, interference due to extremely high titers of antibodies to streptavidin and ruthenium can occur. The test contains additives which minimize these effects.c) High-dose hook effect: A sample with a true concentration clearly above the measuring range, but found within the measuring range.Limits and rangesMeasuring range2‑1000 IU/L (defined by the Limit of Detection and the maximum of the master curve). Values below the Limit of Detection are reported as< 2 IU/L.Values above the measuring range are reported as > 1000 IU/L (or up to 100000 IU/L for 100‑fold diluted samples).DilutionSamples with anti‑HBs concentrations above the measuring range can be diluted with Diluent Universal. The recommended dilution is 1:100 (either automatically by the analyzer or manually). The concentration of the diluted sample must be > 10 IU/L.After manual dilution, multiply the result by the dilution factor.After dilution by the analyzer, the software automatically takes the dilution into account when calculating the sample concentration.Manual dilution can also be made with negative human serum.Note: Antibodies to HBsAg are heterogeneous. In some isolated cases, this may lead to non-linear dilution behavior.Specific performance dataRepresentative performance data on the analyzer is given below. Results obtained in individual laboratories may differ.PrecisionPrecision was determined using Elecsys reagents, samples and controls in a protocol (EP05‑A3) of the CLSI (Clinical and Laboratory Standards Institute): 2 runs per day in duplicate each for 21 days (n = 84). The following results were obtained:cobas e 801 analyzerRepeatability d)Intermediateprecision e)Sample MeanIU/LSDIU/LCV%SDIU/LCV% Human serum 1 4.33 0.224 5.2 0.272 6.3 Human serum 2 12.0 0.237 2.0 0.277 2.3 Human serum 3 475 6.81 1.4 7.55 1.6 PC f) Anti-HBs 1 < 2.00 - - - -PC Anti-HBs 2 83.8 1.08 1.3 1.28 1.5d) Repeatability = within-run precisione) Intermediate precision = between-run precisionf) PC = PreciControlAnalytical specificityNo cross-reactions with HAV, HCV, HEV, CMV, EBV, HIV, Rubella, Toxoplasma gondii, Treponema pallidum, rheumatoid arthritis, autoimmune response or alcoholic liver disease were observed.Measurements were performed on each of the pathogens listed above using ≥ 8 serum or plasma samples which were positive for antibodies to the above-mentioned pathogens.Relative sensitivityPerformance of the Elecsys Anti‑HBs II assay has been assessed by testing a total of 669 samples at two different study sites. 296 samples from vaccinated persons and 373 samples from patients recovered from a hepatitis B infection have been measured with the Elecsys Anti‑HBs II assay and another commercially available fully automated anti‑HBs assay. Discrepant samples were tested with additional anti‑HBs assays to achieve a consensus.Characterization ofsamplesN ElecsysAnti‑HBs IIreactiveAnti‑HBscomparisontest reactiveSensitivity%Anti-HBs positive:vaccinees 296 296 296 100Anti-HBs positive:recovered from ahepatitis B infection373 373 373 100 Total 669 669 669 100 Relative specificityPerformance of the Elecsys Anti‑HBs II assay has been assessed by testing 2673 samples from blood donors negative for anti‑HBs at two different study sites and 1623 anti‑HBs negative samples from laboratory routine at three different study sites. Discrepant samples were tested with additional anti‑HBs assays to achieve a consensus.Characterization of samples N ElecsysAnti‑HBs IIfalsepositiveSpecificity%Anti-HBs negative: blood donors 2673 6 99.78 Anti-HBs negative: routinesamples1623 9 99.45 References1Seeger C, Zoulim F, Mason WS. Hepadnaviruses. In: Field’s Virology, Knipe DM, Howley RM (eds), 2007 5th edition, Lippincott Williams andWilkins, Philadelphia, USA. Chapter 76, pp2977-3029.2WHO. Hepatitis B vaccines. Wkly Epidemiol Rec 2009;84:405-420.3Liaw YF, Chu CM. Hepatitis B virus infection. Lancet2009;373:582-592.4Caspari G, Gerlich WH. The serologic markers of hepatitis B virus infection – proper selection and standardized interpretation. Clin Lab2007;53:335-343.5Kramvis A, Kew M, François G. Hepatitis B virus genotypes. Vaccine 2005;23:2409-2423.6Michel ML, Tiollais P. Hepatitis B vaccines: protective efficacy and therapeutic potential. Pathol Biol 2010;58:288-295.7Elgouhari HM, Abu-Rajab Tamimi TI, Carey WD. Hepatitis B virus infection: understanding its epidemiology, course, and diagnosis. Cleve Clin J Med 2008;75:881-889.8Occupational Safety and Health Standards: Bloodborne pathogens. (29 CFR Part 1910.1030). Fed. Register.9Directive 2000/54/EC of the European Parliament and Council of18 September 2000 on the protection of workers from risks related toexposure to biological agents at workFor further information, please refer to the appropriate operator’s manual for the analyzer concerned, the respective application sheets, the product information and the Method Sheets of all necessary components (if available in your country).A point (period/stop) is always used in this Method Sheet as the decimal separator to mark the border between the integral and the fractional parts of a decimal numeral. Separators for thousands are not used.SymbolsRoche Diagnostics uses the following symbols and signs in addition to those listed in the ISO 15223‑1 standard:CONTENT Contents of kitSYSTEM Analyzers/Instruments on which reagents can be used REAGENT ReagentCALIBRATOR CalibratorVolume after reconstitution or mixingGTIN Global Trade Item NumberCOBAS, COBAS E, ELECSYS and PRECICONTROL are trademarks of Roche. INTRALIPID is a trademark of Fresenius Kabi AB.All other product names and trademarks are the property of their respective owners. Additions, deletions or changes are indicated by a change bar in the margin.© 2016, Roche DiagnosticsRoche Diagnostics GmbH, Sandhofer Strasse 116, D-68305 Mannheim。

COBAS生化仪操作指南

输入最后样本编号
Start 将样本放到定义好的急诊位
Start
4 关机
1C8000 需做关机前保养;请按以下程序执行;在Wash Rack绿架子上加入
Pos W1: Multiclean Pos W2: ISE Cleaning Solution SysClean Pos W3: ISE Activator
Start
单个标本
Save
项目相同
Repeat
输入起始号;回车
急诊样本
Stat
选择样本类型输入样
本位置样本号
手工重测
如果仪器处在Standby或S stop 模式
选择需要重测的样本;编辑需重测的项目;检查样本位置
输入起始号;回车位
Start
选择项目
2 结果浏览
SaveΒιβλιοθήκη WorkplaceData Review
Calibration
Calibrator
Rack Assign
选定标液及空位置
Add
OK
3 应用设置 Utility
3 质控设置
1 质控品装载
Application
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在1 2 3… 中填入定标液的编码;下面填入样本量
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2 安排质控品架号
QC
Chemistry
Install
原装手工
DailyMaintenance设置状态自动运行 C 查看Reagent preparing状态;是否添加试剂
或其他液体一般前一天关机前加好;以备第二天顺利使用 D 查看Calibration情况;准备定标液和定标架
COBAS8000生化仪操作指南
3 COBAS8000生化仪Standby状态操作 A 进行Sample Data Clear清除以往数据 B 进行Calib and QC Select操作;按设置规定

罗氏血气分析仪系列课件罗氏血气培训流程操作快速指南

罗氏血气分析仪系列课件罗氏血气培训流程操作快速指南罗氏血气cobas b 123 POC system安装与培训流程一、检查仪器、试剂、环境准备情况，如果达到要求则连接电源并安装仪器。

二、介绍仪器整体情况。

三、开机，按照屏幕提示执行9步操作并详细介绍。

四、测定程序介绍、示范。

五、更换试剂耗材步骤介绍、示范。

六、介绍各个页面功能：[综述][工作区][仪器][效用]七、让学习人员自己动手操作样本检测、耗材更换，培训工程师当场进行监督、指导。

非常重要！正确的操作会大大减少不必要的故障。

八、强调注意事项：1、血液抗凝必须处理好，检测前充分混合（不能过于剧烈，防止溶血）。

2、建议采血使用动脉血气针；如果使用肝素化的注射器，建议使用2mL容量的型号，采血量要达到1.5mL；如果是5mL容量的注射器，采血量要达到3mL。

3、操作者务必仔细察看屏幕，严格按照屏幕上的指示进行操作，操作者确实完成屏幕指示的动作后，再按下按钮确认。

尤其是更换Sensor Cartridge，请务必仔细观察屏幕指示，做到正确安装。

4、更换Sensor Cartridge后，选择[效用]菜单，用新鲜的血浆（当天的标本）做8次Sensor Cartridge 常规浸润，再做1次Sensor Cartridge 内部常规湿化，接着系统会自动定标，如果有飘红的重复以上步骤浸润和湿化步骤，直至全部项目通过定标。

然后再做两个新鲜全血样本（当天的标本）的测定，进一步活化Sensor Cartridge，整个过程大概需要20多分钟。

请务必在刚刚更换Sensor Cartridge后做好上述活化步骤，过了一段时间再做效果会大大降低。

5、提示使用科室：请保留所有的Sensor Cartridge银色包装袋以及因故障更换下来的Fluid Pack，这些是工程师与罗氏厂家交流维修资料的依据。

九、交流和答疑。

十、留下使用说明和操作快速指南，在仪器合适位置放置工程师名片。

罗氏Cobas6000全自动电化学发光分析仪检测CA153的性能评价

罗氏Cobas6000全自动电化学发光分析仪检测CA153的性能评价发表时间：2018-09-03T14:22:15.413Z 来源：《医药前沿》2018年8月第24期作者：赵有利张尚弟陈丽刘玉梅（通讯作者）[导读] 罗氏Cobas6000型全自动电化学发光分析仪检测CA153的主要分析性能均符合厂商声明的性能和有关的质量要求。

（兰州大学第二医院检验医学中心甘肃兰州 730030）【摘要】目的：对在罗氏公司Cobas6000型全自动电化学发光分析仪上检测的糖类抗原153(CA153)的分析性能进行评价。

方法：参考美国临床和实验室标准化协会性能评价方法和相关报道，并根据临床需求和实际要求，对在罗氏Cobas6000型分析仪测定CA153的精密度、线性范围、生物参考区间和最大稀释倍数4项分析性能进行验证和评价。

结果：批内精密度变异系数(CV)高低值分别为2.67%和3.94%，＜1/4美国临床实验室改进修正法案（CLIA'88）允许总误差(TEa)(6.25%)；批间精密度CV高低值分别为3.68%和2.52%，＜1/3 CLIA'88 TEa(8.33%)；测量线性范围与厂家提供的范围相近；CAl53的测量数值100%在提供的参考区间内。

高浓度的标本可经稀释后再行测定，测定结果显示测定指标的相对偏差在允许误差范围内，具有较高的临床参考价值。

结论：罗氏Cobas6000型全自动电化学发光分析仪检测CA153的主要分析性能均符合厂商声明的性能和有关的质量要求，检测结果准确性较高、可靠性较好，临床参考价值较高，故可满足临床需求。

【关键词】全自动电化学发光分析仪；CA153；性能验证；精密度【中图分类号】R446 【文献标识码】A 【文章编号】2095-1752（2018）24-0057-02 罗氏Cobas6000型全自动电化学发光分析仪可用于多种肿瘤标志物、心肌损害标志物、贫血标志物等80多种生化指标的检测，其采用了国际先进的电化学发光免疫技术，具有操作简单、结果准确、自动化程度高等优点[1-2]。

Cobas c 501分析仪用户操作手册解读

第一章系统概述罗氏Cobas 6000是全自动免疫测定与光度测定分析系统，可定性或定量测定检测项目，Cobas 6000包括两部分：cobas c 501生化分析模块：进行分光光度测定和离子选择电极测定cobas e 601免疫分析模块：进行电化学发光测定下面从控制单元、核心单元、cobas c 501生化分析模块等三部分介绍该系统（cobas e 601免疫分析模块不作介绍）。

1、控制单元A 显示器（连接cobas ） D 触摸式显示器（主机）B 键盘/鼠标（连接cobas） E 键盘/鼠标（主机）C 计算机（连接cobas） F 计算机（主机）G 人体学PC支架2、核心单元1）核心单元轨道A 核心单元 E 模块轨道B 急诊标本位 F 常规标本上机位C 条形码阅读器G 标本退出位D 标本架转盘急诊标本位A 标本架托盘B 标本架C 标本杯、微量杯2）标本架及标本容器标本架不同类型、颜色和相应编号如下：标本容器有三种类型：标本试管、标本杯、定标及质控小瓶标本试管直径为13mm或16mm，长度为75mm或100mm；标本杯可插入16 mm标本试管中用。

A 标本架上的标本杯 D 16mm×100mm试管B 16mm×75mm试管 E 16mm×100mm试管上的标本杯C 16mm×75mm试管上标本杯3、cobas c 501生化分析模块A、B 标本吸样区 E、F 试剂吸样区C 反应盘区 G 试剂盒装载区D ISE模块A、B 标本吸样区A 、B 标本针 D 标本针抽干区C 屏蔽管（防静电） E 标品针冲洗站C 反应盘区A SMS （位置2）、 Multiclean （位置1）B 水位感受器C 超声混合单元D 光度计单元 F 反应盘 G 杯冲洗装置 HHitergent从左往右依次为：Internal standard solution Internal standard solution Diluent solution Diluent solutionReference electrode solution更换以上系统试剂后，进入reagent—status,选择reagent volumn reset 后按ok,仪器即自动更新系统试剂可用量。

cobas 8000日常操作卡

过期试剂报警
OK
罗氏诊断产品（上海）有限公司
邮政编码：200031
技术服务热线：800 820 8864 / 400 820 8864 电话： +86 21 33971000 传真： +86 21 33971888
4
上海市淮海中路1045号淮海国际广场12楼
cobas® 8000 日常操作卡
2、定标设置
批量标本（项目相同）
检查标本测试项目，将标本放在定义的常规标本位
Start
输入起始号，回车
Start
将样本放到定义好的急诊位
急诊样本
Stat
选择样本类型、输入样本位置 (样本号)
选择项目
Save
手工重测
如果仪器处在Standby或S stop 模式选择需要重测的样本,编辑需重测的项目,检查样本位置输入起始号，回车位
Start
Start
2）、结果浏览
Workplace Data Review
4、关机
1）C8000 需做关机前保养，请按以下程序执行,在Wash Rack绿架子上加入 Pos. W1: Multiclean Pos. W2: ISE Cleaning Solution SysClean Pos. W3: ISE Activator Start Start
Reagent Reagent
setting
Reagent Registration
Execute
开放通道（C701模块）： setting Manual Registration Test Name OK
将试剂瓶放入试剂仓在同一空试剂位
注:试剂HIT-D只能在B盘,而NAOH-D和SMS在A和B盘各放一套罗氏诊断产品（上海）有限公司

罗氏Cobas6000全自动电化学发光免疫分析仪条码双工的设置与应用

罗氏Cobas6000全自动电化学发光分析系统是一种用于免疫测定的全自动检测系统。

其作为一种功能强大的实验室诊断工具，具有模块化、灵敏度高、精密度好、检测快、检测项目多、试剂无放射性污染、操作简便、维护方便等特点，广泛应用于各临床实验室[1]。

我院的Cobas6000全自动电化学发光分析系统由2个E601免疫分析模块组成，一直使用非条码双工模式，即先将样本编号，然后在瑞美实验室信息管理系统（LIS）中按顺序扫码录入，再双工到全自动分析仪上完成检测。

2017年6月，我们将该设备设置为条码双工模式，提高了工作效率，减轻了劳动强度，向自动化实验室迈出了关键意义的一步。

现总结近两年的应用经验，将条码双工模式设置方法和应用情况报道如下。

1 条码双工模式通信参数设置（1）关闭通信端口：在Stand By状态下，点击“Start”按钮，将“Host Communication On”设为“Off”。

（2）设置条码双工模式的通信参数：在Stand By状态下，选择页面“Utility”，选择子页面“System”，将“Routine/Stat”设为“Yes”，其他2项设为“No”；在“System”中点击“Host Comm.”按钮，将“Communication Setting”中“RS232C Setting”区域的“Speed”设为“9600”，“parity”设为“8Bit+NONE+2StopBit”，“System”设为“Cobas6000”，“Host”设为“host”，“System ID”为“1”，Host ID为“2”，Communication Trace打勾；在“Text Setting”中进行设置，左侧按照由上而下的顺序依次设置Result Only不打勾（必须）， TS Timeout 打勾，后面为18 Seconds，Auto Rerun TS 不打勾，Manual Rerun TS 不打勾，Stat TS 打勾， TS inquire Always 打勾，TS Ask in Barcode Read Error 打勾，TS Priority Mode不打勾；右侧按照由上而下的顺序依次设置Sample ID 22 Digits 打勾，Change Rack No. 打勾， New Mode 打勾，Send 1st/Rerun Information打勾， Send Concent 打勾，Send Time stamp of pipetting Sample打勾，余下的参数均不打勾；将“Result Upload Setting”中的2个下拉列表中均设置为“by Sample”，余下项目默认，点击“OK”保存设置；在“System”画面上点击“page ?/4”直至到“Page 3/4”，点击“Check Digit Setting”，将Code 39 打勾，NW 7打勾，下拉列表选中“Modulus 16”。

Cobase411电化学发光免疫分析仪用户操作手册分析

cobas e411（Disk）操作手册罗氏诊断产品（上海）有限公司广州分公司第一章一．二．三．四．五．第二章一．二．1．2．3．三．1．2．3．四．第三章一．二．三．四．五．第四章第一章系统概述一．e411主要部件A：操作开关 B：样本（30个位置）／试剂区（18个位置，具自动开关盖装置） C：测试区 D：消耗品区 E：显示及控制单元位于仪器右侧面位于仪器左侧面A：主电源开关 B：电源线 A：USB接口 C：HOST接口二．控制单元三．样品／试剂区A ：取样区B ：样品盘保护盖 A ：磁珠搅拌针 B ：冲洗站C ：样本/试剂针BA ：触摸屏B ：虚拟键盘（触摸屏幕上需输入内容区域时，自动在屏幕下方跳出）C ：数字键盘 A ：定标/质控条形码阅读口B ：带开关盖装置的试剂仓（18个位置） CA B四．测试区A ：孵育池（共32个孵育位）B ：吸样位A ：系统试剂保护门B ：Sipple 针C ：CleanCell （黑盖）D ：ProCell （白盖）五．消耗品区BDCA ：吸头位1-2B ：反应杯位3-5C ：吸头丢弃位D ：反应杯丢弃位废吸头/反应杯盒 A：蒸馏水桶 B：废液桶BABA：抓手B：抓手移动时的横纵轴C：吸头/反应杯区1（120个吸头，60个反应杯）D：吸头/反应杯区2（120个吸头，60个反应杯）E：吸头/反应杯区3（120个吸头，60个反应杯）第二章基本操作一．开机a．检查蒸馏水桶，将SysWash浓缩液配置为1:100的系统用水b．清空废液桶c．打开ProCell和CleanCell盖子，关好系统试剂保护门。

注意：运行过程中不能打开系统试剂保护门，否则仪器将停止运行。

d．打开仪器右面主电源开关，再打开仪器前面操作开关，等界面出现后，录入用户名和密码，仪器自动初始化后进入待机状态注意：仪器分不同级别及权限使用，可根据实际情况设定；添加用户名后，第一次输入的密码即为以后的密码。

罗氏Cobas C501生化仪的保养操作流程

四、C501每月保养
（四）清洗Detergent 1&2 过滤器
四、C501每月保养
（五）清洁滤网
【过滤网脏，可能会引起仪器散热效率低和仪器故障】 ➢ 1、关机或待机状态下 ➢ 2、用吸尘器清洁机器前部滤网除尘
五、C501每两月保养
更换测试电极
【定期更换(Na K Cl)测试电极, 以预防结果问题的发生】 ➢ 1、关机或待机状态下。 ➢ 2 、拔除电极信号线。 ➢ 3 、取出旧的电极。 ➢ 4 、清洁电极腔体。 ➢ 5 、安装新的电极。
三、C501每周保养
（四）清洁内标液缓冲池
四、C501每月保养
（一）清洁ISE参比液过滤器
【过滤器堵，可能会引起仪器故障】每月执行一次，根据仪器使用情况按需执行。 ➢ 1、关机或待机状态下。 ➢ 2 、盖上专用盖。 ➢ 3 、从参比液瓶中取出过滤器，用去离子水冲洗。 ➢ 4 、旋紧管端的过滤器并将其放回瓶内。 ➢ 5 、执行试剂灌注。
三、C501每周保养
（三）清洁各针冲洗站
【冲洗池脏，可能会引起携带污染】 ➢ 1、关机或待机状态。 ➢ 2、使用棉签擦拭所有冲洗池。 ➢ 3、每个冲洗站注入100ml去离子水清洗。
三、C501每周保养
（四）清洁内标液缓冲池
【内标液缓冲池脏，可能会引起ISE结果问题】 ➢ 1、关机或待机状态。 ➢ 2、拧松螺丝取出内标液缓冲池。 ➢ 3、用去离子水冲洗内标液缓冲池内的结晶。 ➢ 4、排出池内的水，将内标液缓冲池装回仪器。
和孵育盘。 ➢ 4、用棉签擦拭超声混匀器附近。冲洗孵育盘过滤器。
四、C501每月保养
（三）清洁孵育池
四、C501每月保养
（四）清洗Detergent 1&2 过滤器

罗氏cobas 8000日常操作

Routine QC Assign Standby bottle QC
选择常规质控，及推荐的定标，并放好架子，按开始有其他要求，按照下面进行定标质控：
选择质控项目
Select
Save
加载质控品
Start
Start
质控结果查看
QC
Run Status
可以浏览所有项目的质控结果
DM
Workplace
输入序列号和样本号
单个标本
批量标本（项目相同）
Save Repeat
OK
输入最后的样本编号
Start
输入不同类型标本的起始号
Start
Stat
输入急诊架子号和样本位置
选择项目
Save
加载标本
Start
Start
手工重测
Workplace
Data Review
选择需要重测的标本
Test Selection
cobas 8000 data manager QC parameters *
QC Routine 开始定标
Calibration
选择时间、模块、指控品、项目
Refresh
Status
Module选择
选定定标项目及定标方法
Save
加载定标液
Start
Start
1
cobas® 8000 日常操作卡
Daily Maintenance Sample Data Clear Reagent Preparing Calib. And QC Select
设置为自动执行
选中 clear
OK
开始质控 QC
OK
（同时务必每天删除DM中使用序列号模式的样本结果）

cobas

e、两天到七天停机：执行保养Maintenance— POWER OFF2 ，开机执行 POWER ON2 如果关机超过七天，请与罗氏公司当地售后人员联系。
培训时设置 POWER ON: (c501) Air Purge—Incubation Water Exchange —Reagent prime—IS bath
Stop
1 Reset
Select
c、关机保养（仪器在Stand by状态下方可进行）
Utility
Maintenance
POWER OFF*
Select
Execute
d、绿架子冲洗
绿架子一号位放 Multi-clean洗液，二号位放ISE Cleaning Solution，三号位放Activator，放急诊位后按START
POWER OFF2: (e601) Reagent Prime (Pre-wash probe 5)— Reagent Prime (Reagent 5)— Empty PC/CC Reservoir—Pre-wash Sipper Air Purge (10)
5
cobas® 6000 日常操作卡
POWER ON2 : (e601) Sipper Air Purge (5)—Pipetter Air Purge (10)—Reagent Prime (pre-wash probe 5)—Reagent Prime (Reagent 2)—MC Preparation (30) POWER OFF ： Reagent Prime — Finalization WEEKLY : (c501) Wash Reaction Parts—Cell Blank Measurement—IS Bath Cleaning

Cobase电化学发光免疫分析仪用户操作手册

cobas e411 (Disk )操作手册罗氏诊断产品（上海）有限公司广州分公司目录第一章系统概述 • 一. e411主要部件 ---------------------- 二. 控制单元一三. 样品/试剂区 ------------------------四.测试区 ----------------------------五. 消耗品区 ---------------------------A :操作开关C :测试区位于仪器右侧面2 2 33 4 4666 6 67 9 9 10 10 10 12 12 12 13 14 15 16 第二章基本操作第一章系统概述e411王要部件B :样本（30个位置）/试剂区（18个位置，具自动开关盖装置）D :消耗品区E :显示及控制单元位于仪器左侧面A :主电源开关B :电源线 A : USB 接口C : HOST 接口控制单元A :系统试剂保护门B : Sipple 针C : CleanCell （黑盖）D : ProCell （白盖）三.样品/试剂区A :磁珠搅拌针 C :样本/试剂针A :定标/质控条形码阅读口四带开测试区试剂仓A B™ 和片FI 廿rn|A :触摸屏B :虚拟键盘（触摸屏幕上需输入内容区域时，自动在屏幕下方 I 鱼七跳岀）C :数字键盘A :孵育池（共183个位个孵育位）B :吸样位BAA :取样区B :样品盘保护盖 -CAB :冲洗站A:系统试剂保护门B: Sipple针C: CleanCell （黑盖）D: ProCell （白盖）五.消耗品区用水Db. 清空废液桶c.打开ProCell 和CleanCell 盖子，关好系统试剂保护门。

注意：运行过程中不能打开系统试剂保护门，否则仪器将停止运行。

d. 打开仪器右面主电源开关，再打开仪器前面操作开关，等界面岀现后，录入用户名和密码，仪器自动初始化后进入待机状态注意：仪器分不同级别及权限使用，可根据实际情况设定；添加用户名后，第一次输入的密码即为以后的密码。

罗氏Cobas（R）8000全自动生化分析仪日常操作注意事项

罗氏Cobas（R）8000全自动生化分析仪日常操作注意事项
罗氏Cobas?8000全自动生化分析仪日常操作注意事项王聪，赵凤梅
【期刊名称】医疗装备
【年(卷),期】2014(027)011
【总页数】1
罗氏Cobas?8000全自动生化分析仪由做生化的C701、C502模块，做离子的ISE模块和做发光的e602模块组成。

现将在使用过程的操作注意事项总结如下，与同行共同学习。

1 水质
1.1 水质的要求
细菌数<10cfu/mL; 导电性<1.0μS/cm；水压：50-340kpa;水温>12℃;出水量必须>100L/h。

1.2 不合格水质对仪器的影响
可影响某些项目结果准确度( ISE 单元,CA.MG等相关项目)；样品针及试剂针问题(e602模块样品针LLD 报警,试剂针检测试剂量异常)；对生化模块光路系统的影响，造成如孵育盘, 反应杯, 灯泡的提前老化。

2 仪器的冲洗液
仪器系统试剂NAOH、SMS、Hitergent量要保证充足，以便仪器顺利完成开机保养、周保养等。

建议设置系统试剂最小量报警，要在每天关机前确认：每一个试剂盘内NAOH的量保证701模块>63 mL，502模块>58 mL，Hitergent试剂最少量为20mL。

3 试剂准备。

罗氏cobas6000标准操作程序.

罗氏cobas6000仪器标准操作程序1 目的建立规范标准的罗氏cobas6000仪器标准操作程序。

2 范围适用于生化科和授权的检验专业人员操作使用。

3 责任由经过培训合格后，并经授权的检验专业技术人员操作，由生化科主任负责技术指导和质量监督。

4 定义cobas 6000系统是全自动随机存取软件控制的免疫测定与光度测定分析系统，在设计上采用种类繁多的测试，完成定性和定量的体外测定工作。

cobas 6000系统是一种功能强大的完整的诊断实验自动化工具。

它把生化测定分析模块（c501），离子选择电极（ISE）、光度测定分析单元以及免疫测定分析模块（e601）结合在一起，使之最优化，以适应高通过能力的作业量。

5 程序5.1 仪器简介cobas6000 是罗氏诊断公司出品的全自动免疫测定与光度测定的分析系统，可定性或定量测定检测项目，cobas 6000包括两部分：cobas c501生化分析模块：进行分光光度测定和离子选择电极测定cobas e601免疫分析模块：进行电化学发光测定系统特色：可以24小时待机使用标本条码扫描功能试剂条码扫描功能自动保养功能作业指导书第1页共17页自动复查功能自动发出定标信息自动标本稀释功能双向数据传输接口系统辅助的操作流程e601免疫分析模块：单个E模块的每小时处理能力为170个试验一个E模块具有25个温控的试剂通道1个模块可以安放672个反应杯1个模块可以安放672个加样头c501生化分析模块：同时分析项目: 60 比色分析和3 离子分析分析速度1000 tests/hr. (600 tests/hr.比色法)118个参数在线试剂装载特殊血清指数HbA1c 全血检测无接触超声混匀技术5.1.1运行条件水质要求：无菌(< 10 cfu/ml)，去离子水1.5 MΩ电阻值(最大1.0 Ms/cm)15-25 磅/英寸2 (0.5~3.5 kg/cm2 或49~343 kpa)耗水量：每e170模块消耗18L/h每c501模块消耗15 L/h，去离子水供应量必须为40L/h或更多环境条件：无灰尘的、良好通风的环境作业指导书第2页共17页无直接日照地面水平(角度：<1/200 º)地面足够坚硬能够承受仪器的重量(详细情况请见本章中的系统特点)温度：18~32摄氏度当系统启动时，温度的改变应该小于2度/小时屋内湿度：45%~85%电源电压没有明显的波动在附近没有会产生电磁波的仪器有接地的三相电源5.2 仪器安全在仪器设备上面和周围不要使用可燃性危险品，避免引起火灾和爆炸。

罗氏cobas-e601化学发光免疫分析仪标准操作程序

罗氏cobas e601化学发光免疫分析仪操作程序1目的正确使用与维护罗氏c obas e601全自动化学发光免疫分析仪。

2仪器简介、工作原理2.1 仪器名称：全自动化学发光免疫分析仪2.2 仪器型号：罗氏cobas e6012.3 生产厂商：罗氏诊断公司德国2.4仪器简介：cobas e601是采用目前国内、外最先进的电化学发光免疫分析技术（ECLIA），该技术在发光反应中加入了电化学反应，应用理想的标记物，标记物三联吡啶钌分子结构简单，可标记任何抗原、抗体、核酸等，稳定性好，可确保检测结果的重复性好，无放射性、可避免对人体和环境的危害。

ECLIA是继放射免疫、酶免疫、荧光免疫、化学发光免疫之后的新一代标记免疫测定技术。

该仪器秉承罗氏公司模块化设计，为实验室提供优秀服务。

3仪器运行环境3.1 环境条件为了确保系统操作的正常运转，应该保证以下的条件。

3.1.1 无尘良好通风的环境，无直接日照。

3.1.2 温度：18-32℃，温度的改变应该小于2℃/小时，屋内湿度：30%-80%。

3.1.3 输入电压220V（+/- 10％）50HZ，有良好接地的电源，单独接地线，对地阻抗小于10Ω，零地电压小于2V,仪器功率11KV A，建议UPS功率大于15KV A。

3.1.4 在附近没有会产生电磁波的仪器，环境噪音<85dB（A）。

3.2 供水要求3.2.1无菌去离子水(要求<10 cfu/ml，电导率≤1μS/cm), 水量: c701为50 L/h, c502为40 L/h，水压为0.5-3.5kg/cm2。

3.2.2 纯水水箱出水管口径1/2inch(约12mm内径），地面排水口距仪器排水出口在50--100mm，管长应小于5m。

3.3 操作人员3.3.1要求操作人员熟知相关指导方针与标准以及操作员手册中包含的信息与程序。

操作人员需要接受过罗氏诊断公司的培训，要求操作人员已仔细遵循操作员手册中详细说明的系统操作与维护程序，并取得罗氏公司培训合格的证书。

罗氏cobas 6000 e601全自动电化学发光免疫分析仪性能验证

罗氏cobas 6000 e601全自动电化学发光免疫分析仪性能验证冯磊;徐文波;张大莲;张兴锋;代艳娟;毛星星;罗曼玲【期刊名称】《医疗装备》【年(卷),期】2014(027)012【摘要】目的:罗氏cobas 6000e601全自动电化学发光免疫分析仪进行仪器性能验证.方法:依照罗氏公司提供的全自动免疫分析仪性能验证程序,对试剂仓温度准确性及波动、孵育盘温度准确性及波动、测量池温度准确性及波动、加样系统准确性与重复性、交叉污染及灵敏度共计7项性能进行验证.结果:罗氏co-bas 6000e601全自动电化学发光免疫分析仪各项性能指标与厂商规定的分析性能基本一致,符合质量目标要求.结论:验证方案可操作性和实用性强,除可用于实验室管理机构的相关认证及认可工作,还可为仪器故障的诊断及处理提供依据.【总页数】2页(P8-9)【作者】冯磊;徐文波;张大莲;张兴锋;代艳娟;毛星星;罗曼玲【作者单位】玉溪市人民医院检验科,云南玉溪653100;玉溪市人民医院检验科,云南玉溪653100;玉溪市人民医院检验科,云南玉溪653100;玉溪市人民医院检验科,云南玉溪653100;玉溪市人民医院检验科,云南玉溪653100;玉溪市人民医院检验科,云南玉溪653100;玉溪市人民医院检验科,云南玉溪653100【正文语种】中文【中图分类】R197.39【相关文献】1.罗氏Cobas e601电化学发光免疫分析仪FT3、FT4、TSH生物参考区间验证及设定 [J], 靳仙宝;杨宜娥;刘敏2.罗氏Cobas 6000全自动电化学发光分析仪检测AFP，CEA的性能验证 [J], 杨丽;何叶莉;王晗;卞成蓉;王卫东;徐军;刘佳3.罗氏COBAS6000全自动电化学发光免疫分析仪性能验证 [J], 谭晓辉;王勇4.罗氏Cobas6000全自动电化学发光免疫分析仪条码双工的设置与应用 [J], 刘性君5.罗氏Cobas E601全自动电化学发光免疫分析仪检测癌胚抗原(CEA)的临床分析[J], 杨寿林;吴路发;李勇因版权原因，仅展示原文概要，查看原文内容请购买。

罗氏COBAS6000全自动电化学发光免疫分析仪性能验证

罗氏COBAS6000全自动电化学发光免疫分析仪性能验证谭晓辉;王勇【摘要】目的按ISO15189要求对罗氏COBAS 6000全自动电化学发光免疫分析仪的性能进行验证. 方法对甲胎蛋白(alpha-fetoprotein,AFP)的精密度、准确度、临床可报告范围(clinical reportable range,CRR)、分析测量范围(analytical measurement range,AMR)、参考区间进行验证实验. 结果批内精密度变异系数(coefficient variation,CV)高低值分别为3.28%和3.46%;日间精密度CV高低值分别为4.39%和5.13%,均小于厂家提供的CV(10%).相对偏差为0.862%,小于5%.分析测量范围为0.80-1 200 ng/ml,参考区间为0-20.00 ng/ml,临床可报告范围为0-60 000 ng/ml. 结论罗氏COBAS 6000全自动电化学发光免疫分析仪的性能与厂家提供的资料基本一致,故可用其进行临床标本的检验工作,所得结果具有可信性.%Objeaive To test and verify the system performance of Roche COBAS 6000 automatic electrochemiluminescence immunoassay analyzer according to the requirements of IS015189. Methods Verification experiments were taken to measure the precision.accuracy , clinical reportable range( CRR) , analytical measurement range ( AMR ) , reference interval of alpha-feloprotein ( AFP) . Re-sults The high and low values of coefficient variation( CV) of inter-assay were 3. 28％ and 3. 46％ , and those of between-day precision were 4. 39％ and 5. 13％ , which were all less than the CV provided by the manufacturer( 1O％ ) . Relative bias was 0. 862％ . Analytical measurement range was 0.80 - 1 200 ng/ml.the reference interval was O - 20. 00 ng/ml, and the clinical reportable range was O 60 000 ng/ml. Conclusion The basicperformances of Roche COBAS6000 automatic electrochemiluminescence immunoassay analyzer are consistent wich the data provided by the manufacturer,so it can be used to inspect the clinical samples and the results are credible.【期刊名称】《山西医科大学学报》【年(卷),期】2011(042)001【总页数】4页(P52-55)【关键词】罗氏COBAS 6000全自动电化学发光免疫分析仪;甲胎蛋白;性能验证【作者】谭晓辉;王勇【作者单位】南方医科大学法医系,广州,510515;重庆市公安局刑警总队技术处【正文语种】中文【中图分类】R318.6罗氏COBAS6000全自动电化学发光免疫分析仪(以下简称6000)是国内医疗检验的大型主力检测系统，它是当今肿瘤标志物检测灵敏度最高的仪器，其出色的检测性能得到国内外实验室的一致认同。

罗氏Cobasc501生化分析仪日常操作卡

操作人员需经过专业培训，熟悉仪器操作流程和注意事项。
操作时应佩戴必要的防护装备，如实验服、防护眼镜、实验手套等。
避免使用未经批准的试剂和耗材，确保仪器正常运转和实验结果的准确性。
设备安全
01 定期对仪器进行维护和保养，确保设备性能稳定和延长使用寿命。
02 仪器出现故障时，应立即停止使用，并及时联系专业人员进行检修。
设备特点
01
02
03
高通量
Cobas c501具有较高的检测通量，能够同时进行多个项目的检测，提高了实验室的效率。
准确性
该仪器采用先进的检测技术，确保检测结果的准确性，为临床诊断和治疗提供可靠的依据。
自动化
Cobas c501具有较高的自动化程度，减少了人工操作的误差和繁琐性。
设备应用范围
详细描述
总结词：仪器无法正常启动，可能是由于电源故障、硬件
故障或软件问题。
01
02
03
检查电源插头是否牢固插入电源插座，并确保电源正常。
检查仪器硬件是否正常，如电源模块、控制板等。
04
05
如果问题仍然存在，尝试重新启动仪器或联系技术支持。
常见问题二：试剂针堵塞
总结词：试剂针堵塞可能导致加样不准确或无法加样。
Cobas c501适用于临床实验室的生化检测，可检测包括酶类、糖类、脂类、蛋白质等多个领域的生化指标。
该仪器也可用于科研和药物研发等领域，为科研人员提供准确的生化数据。
02
操作流程
开机准备
开机检查
确认仪器正常，无故障提示，检查电源连接是否稳定。
仪器清洁
使用专用清洁剂擦拭仪器表面，确保仪器清洁无尘。

罗氏 cobas 6000 生化免疫分析仪简易操作手册

罗氏cobas 6000生化免疫分析仪简易操作手册罗氏诊断产品（上海）有限公司目录第一章系统概述1、控制单元......................................................................... .. (3)2、核心单元......................................................................... (4)3、cobas c 501生化分析模块..................................................... .. . .. (7)4、cobas e 601免疫分析模块..................................................... .. . .. (10)第二章软件系统简介1、系统状态概览......................................................................... .. (15)2、日常工作菜单......................................................................... .. (16)第三章基本操作1、开机......................................................................... ................ .. (17)2、开机后确认......................................................................... . (18)3、申请新项目......................................................................... . (18)4、申请新校准品......................................................................... (25)5、申请新质控物.............................................. .... ........... .... ........ . . (27)6、校准................ ......................................................... ....... ......... .. (28)7、质控................... ............................................................ (30)8、标本检测............. ............................................................ (32)9、基本操作注意事项............................................................ . (34)第四章维护保养1、每日保养......................................................................... . (35)2、每周保养......................................................................... .. (36)3、每两周保养......................................................................... . (37)4、每月保养.................................................................... . (38)5、每两月保养........................................................................ .. (38)6、每季保养....................................................................... . (39)7、每半年保养................................................................. ......... . (39)7、按需保养......................................................................... . (40)8、保养项目设置...................................................................... . (40)第五章仪器报警信息 (37)第一章系统概述罗氏cobas 6000是全自动免疫测定与光度测定分析系统，可定性或定量测定检测项目，cobas 6000包括两部分：cobas c 501生化分析模块：进行分光光度测定和离子选择电极测定cobas e 601免疫分析模块：进行电化学发光测定下面从控制单元、核心单元、cobas c 501生化分析模块、cobas e 601免疫分析模块等四部分介绍该系统。